GLIVEC - GLIVEC - CT 5029 - English version

pages

English

Documents

2007

Écrit par
Has

Publié par
haute-autorite-sante-cancers

Lire un extrait

Obtenez un accès à la bibliothèque pour le consulter en ligne En savoir plus

Découvre YouScribe et accède à tout notre catalogue !

Je m'inscris

Découvre YouScribe et accède à tout notre catalogue !

Je m'inscris

pages

English

Documents

2007

Lire un extrait

Obtenez un accès à la bibliothèque pour le consulter en ligne En savoir plus

Publié par

haute-autorite-sante-cancers

Publié le

07 novembre 2007

Licence :

En savoir +

Langue

English

Introduction GLIVEC 100 mg film-coated scored tablets Box of 60 tablets (CIP: 362 247-5) GLIVEC 400 mg film-coated scored tablets Box of 30 tablets (CIP: 362 249-8) Posted on May 20 2008 Active substance (DCI) imatinib (mesilate) ATC Code L01XE01 Laboratory / Manufacturer NOVARTIS PHARMA S.A.S. GLIVEC 100 mg film-coated scored tablets Box of 60 tablets (CIP: 362 247-5) GLIVEC 400 mg film-coated scored tablets Box of 30 tablets (CIP: 362 249-8) Posted on May 20 2008

Voir

Publié par

haute-autorite-sante-cancers

Publié le

07 novembre 2007

Licence :

En savoir +

Langue

English

The legally binding text is the original French version

TRANSPARENCY COMMITTEE OPINION 7 November 2007 GLIVEC 100 mg film-coated scored tablets Box of 60 tablets (362 247-5) GLIVEC 400 mg film-coated scored tablets Box of 30 tablets (362 249-8) Applicant: NOVARTIS PHARMA S.A.S. imatinib (mesilate) List I Initial 6-month hospital prescription and renewal restricted to haematology, oncology, internal medicine and gastroenterology specialists. Orphan medicinal product status Date of Marketing Authorisation (centralised European procedure): 7 November 2001 Marketing Authorisation (MA) revision: 24 May 2002 (1st extension of indication for gastrointestinal stromal tumours) 19 December 2002 (2nd extension of indication for chronic myeloid leukaemia (CML) as first-line treatment) 13 September 2006 (3rd extension of indication for Ph+ ALL) 28 November 2006 (extension of indication to be evaluated). Reason for request: Inclusion on the list of medicines reimbursed by National Insurance and approved for hospital use for “the treatment of myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene rearrangements". Health Technology Assessment Division

Voir